1. Field of the Invention
The present application relates to crystalline forms of gemcitabine base, as well as processes for the preparation thereof.
2. Description of the Related Art
Gemcitabine is a nucleoside analog used as chemotherapy. Gemcitabine has the following structure:
Its chemical name is 4-amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl) tetrahydrofuran-2-yl]-1H-pyrimidin-2-one, chemical formula is: C9H11F2N3O4; molecular weight is 263.198 g/mol.
The discovery of new polymorphic forms of a pharmaceutically useful compound provides a new opportunity to improve the performance characteristics of a pharmaceutical product. It enlarges the repertoire of materials that a formulation scientist has available for designing, for example, a pharmaceutical dosage form of a drug with a targeted release profile or other desired characteristic.
There is a need in the art for various polymorphic forms of gemcitabine.